MAUDE Adverse Event Report: ST. JUDE MEDICAL PACEL FLOW DIRECTED PACING CATHETER; ELECTRODE, PACEMAKER, TEMPORARY

Model Number 401762

Device Problems Pacing Problem (1439); Improper or Incorrect Procedure or Method (2017)

Patient Problem Arrhythmia (1721)

Event Date 01/31/2022

Event Type  Injury  

Event Description

Following a transcatheter aortic valve implantation procedure, in the evening the patient was brought in for a temporary lead implant with an external pacemaker.The patient was noted to be displaying bradycardia with a heartbeat of 38 beats/minute with lability.Following the procedure, the patient went into cardio-respiratory arrest and was sent for cardiac resuscitation.The patient was then recovered via cardiac massage.It was noted that the temporary lead had not been functioning.The external pacemaker and the lead cable were exchanged, and then the temporary lead was repositioned, but the temporary lead still only functioned intermittently.The temporary lead was noted to be fixed to the patient by being sutured to the skin.This was then determined to be the issue as the sutures were overtightened and caused the conductor to break and the catheter not to pace.The patient was implanted with a non-abbott single-chamber pacemaker on (b)(6) 2022 and was discharged on (b)(6) 2022 with no complications related to the cardio-respiratory arrest.

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information received, the cause of the reported pacing issue and subsequent cardio-respiratory arrest could not be conclusively determined.

Manufacturer Narrative

Additional information: g3, h2 (medical device problem code - 2017 - improper or incorrect procedure or method added).Corrected information: h2 (investigation conclusions), h10.The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information received, the cause of the reported incident was attributed to overtightening of the sutures by the user.

• Brand Name: PACEL FLOW DIRECTED PACING CATHETER
• Type of Device: ELECTRODE, PACEMAKER, TEMPORARY
• Manufacturer (Section D): ST. JUDE MEDICAL; 14901 deveau place; minnetonka MN 55345 2126
• Manufacturer (Section G): ST. JUDE MEDICAL; 14901 deveau place; minnetonka MN 55345 2126
• Manufacturer Contact: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 13716862
• MDR Text Key: 287185468
• Report Number: 2182269-2022-00013
• Device Sequence Number: 1
• Product Code: LDF
• UDI-Device Identifier: 05414734001045
• UDI-Public: 05414734001045
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K161873
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2022
• Device Model Number: 401762
• Device Catalogue Number: 401762
• Device Lot Number: 8025213
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/22/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention